This course will show the FDA&rsquo\
;s requirements for dietary supplement manufacturing and teach how to impl
ement the concepts in a plant and manage the compliance requirements using
the quality management system approach.

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This course will presen
t the following.

\n\n\n

GMP requirements for dietary supplement
manufacturers.

\n

The FDA&rsquo\;s interpretation of 21 CFR Part
111 GMP requirements.

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How to develop a Quality Management Syste
m for implementing the GMP requirements.

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How to implement a Qua
lity Management System for compliance to the FDA GMP requirements.

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How to manage the Quality Management System.

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The roles and
skill sets required for plant personnel to successfully develop\, implemen
t and manage a Quality Management System.

Learn about the Personnel interactions required to develop\, implem
ent and manage a Quality Management System.

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Wh
o will Benefit:

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Personnel with responsibilities for quality wil
l be benefit from this seminar. The following job descriptions should atte
nd.

\n\n\n

Quality Managers

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Production Managers and
Plant Managers

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Quality Technicians

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Plant Engineers
li>\n

Purchasing Managers

\n

R&amp\;D scientists

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&nbsp\;\n\n

Topic Background:

\n\n

The FDA gives guidance to diet
ary supplements manufacturers through 21 CFR Part 111. A thorough understa
nding of the regulations and their interpretation by the FDA is necessary
to apply the requirements in a plant. The application of the regulations r
equires developing processes and procedures.

\n\n

The FDA&rsquo\;s 21
CFR Part 111 is a list of specific Good Manufacturing Practice (GMP) requ
irements for how dietary supplements should be manufactured\, packaged\, l
abeled and held. The FDA publishes the preamble to 21 CFR Part 111 as a co
mpanion to the GMP requirements. The preamble is the FDA&rsquo\;s interpre
tations of its GMP requirements. It is the FDA&rsquo\;s responses to quest
ions submitted about the requirements.

\n\n

The GMP requirements can
be applied in a using a Quality Management System (QMS) approach. A QMS is
a list of procedures and policies that translates the GMP requirements to
a set of executable processes. Understanding the FDA&rsquo\;s interpretat
ion of the GMP&rsquo\;s is important in helping plants develop their proce
sses and procedures. Processes and procedures and how they are executed by
plant personnel are important in determining whether compliance to the FD
A&rsquo\;s GMP requirements will be achieved. Processes and procedures nee
d to be simple and direct. The roles and responsibilities of plant personn
el and their interactions with the QMS are also important and need to be c
learly defined.

Requi
rements for Components\, Packaging and Labels &ndash\; Those received for
use in the production of dietary supplements and finished dietary suppleme
nts received for packaging and labeling\, rejected packaging\, labels and
components.